Comparison of PMS between China and EU
April 4, 2023In China, Post-Market Surveillance (PMS) is an important component of the regulation for medical devices, ensuring the safety and effectiveness of these products. It is overseen by NMPA (National Medical Products Administration). This article will outline the key points about the PMS in China and compare the PMS between China and EU.
Keep These Definitions in Mind
In China, a medical device adverse event refers any harmful event that occurs while using marketed medical devices under normal conditions and causes or is likely to cause harm to the human body.
Under MDR: ‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device;
‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect;
Serious damage is defined in Chinese Provisions for Medical Device Adverse Event Monitoring and Re-evaluation as the damage that one of the following situations is met:
- Life threatening;
- Causing permanent harms to body function or injuries to body structure;
- Medical measures are required to avoid the above-mentioned permanent harms and injuries.“
Under MDR: ‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following:
- the death of a patient, user or other person,
- the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
- a serious public health threat;
Group adverse event of medical device refers to the events occurred by the same medical device during its use that causes harm or threat for the health or life safety of a certain amount of population within a relatively concentrated time and area.
Medical device marketing authorization holders (MAHs) refer to the holders of medical device registration certificate and filing certificate, namely, medical device MAHs and filing persons.
Responsibilities on MAHs
MAHs are responsible for conducting continuous research on medical devices already marketed, evaluating risks, monitoring adverse events associated with medical devices, implementing effective control measures based on analysis and evaluation results, and fulfilling the following main obligations:
- Establish a medical device quality management system that includes a working procedure for monitoring adverse events and re-evaluation of medical device;
- Equip with the appropriate organization and personnel to carry out the PMS work;
- Proactively collect and truthfully and promptly report medical device adverse events to the surveillance authorities within the timeframe specified in the regulations;
- Promptly investigate, analyze and evaluate medical device adverse events and promptly take risk control measures and publish risk information;
- Conduct a continuous study of the safety of medical devices once they are on the market and prepare periodic risk evaluation reports as required;
- Actively conduct medical device re-evaluation;
- Cooperate with NMPA in the investigation of medical device adverse events
Overseas MAHs should also establish an information sharing mechanism with their designated agents to exchange information on the monitoring and re-evaluation of medical device adverse event.
PMS Management System
The MAH should establish a PMS management system, including following aspects:
- Leading Group. MAHs should establish a leading group with the person in charge of the enterprise as the team leader, and composed of personnel from R&D, production, sales, after-sales and adverse event monitoring departments to comprehensively lead, organize, and manage medical device adverse event monitoring.
- PMS departments and personnel. PMS personnel should have received professional training in medical device adverse event monitoring, be familiar with relevant regulations on medical device adverse event monitoring, have professional knowledge of medical devices, be familiar with the characteristics of the medical devices they hold, and have good communication and coordination skills. PMS personnel are responsible for collecting medical device adverse event reports, and reporting to NMPA in a timely manner, as well as organize the writing of PMS work procedures, emergency plans and other documents.
- PMS training should cover all enterprise personnel. The training content should include current relevant laws and regulations, PMS working procedures, relevant knowledge of PMS, analysis and evaluation methods, and knowledge of rational equipment use, etc. After the training, the training effect should be evaluated using questionnaires and written exams.
- Investigation. Adverse events that cause death or serious injury, or that have the potential to cause serious injury or death, should be investigated. The main content of the investigation includes the product quality status, the correlation between the injury and the product, etc.
- Emergency response. When a medical device adverse event requires an emergency response, the MAH should take necessary risk control measures in a timely manner, such as discontinuation of use, cessation of sale, recall, etc.
- Monitoring records. Records should be kept for at least 2 years after the shelf-life expiration of medical devices; for those without a shelf life label, the record-keeping period should not be less than 5 years; and monitoring records for implantable medical devices should be retained permanently.
Reporting of Adverse Event
In China adverse events should be reported according to the "Report when in Doubt" principle. If an event suspected of being a medical device adverse event should be reported as such. In the EU, manufacturers shall report any individual serious incident after they have established the causal relationship between that incident and their device or that such a causal relationship is reasonably possible. However, in the case of a serious public health threat, the report referred shall be provided immediately without causal relationship.
The suspicious adverse event should be reported through the NMPA online platform https://www.cdr-adr.org.cn/ylqx_1/Medical_blsjbg/. Overseas MAHs of imported medical devices and the MAHs exporting domestic medical devices abroad shall voluntarily collect the adverse events occurring abroad and report adverse events causing or potentially causing severe injuries or death within 30 days of identification or notification.
The following table compares the reporting periods in China and the EU.
Analysis and Evaluation of Adverse Event
After reporting, the manufacturer should analyze the adverse event. The most important contents of the assessment include:
- whether the device complies with mandatory standards, and the registered or filed technical specifications;
- whether any malfunction or injury occurred during the use of the medical device;
- whether it would cause injury under the normal conditions of use, and whether there are scientific literatures, researches, relevant tests, or verifications that can explain the cause of the injury;
- the region and the characteristics of the population affected in the injury;
- the severity of injury to human health;
- the probability of injury;
- the short-term and long-term consequences of injury;
- other factors that may cause injury to the human body.
Risk Control
When the MAH discovers that there are medical devices with unreasonable risks that may endanger human health and life safety, it should take appropriate control measures depending on the risk situation, e.g. stopping product production and sales and notifying relevant user to suspend use; implementing product recall; issuing risk warning information ; conducting self-examination and rectification of the production quality system; revising label and IFU; improvement process, design, product technical requirements etc..
If medical devices are subject to control measures due to adverse events abroad, the registrant should report the adverse events, control measures and the subsequent disposal in China to NMPA within 24 hours.
When the understanding of the safety and effectiveness of the medical device changes, the monitoring and evaluation results of adverse events show that the medical device may be defective, or the NMPA requires, the MAH should re-evaluate the medical device and take appropriate risk control measures based on the re-evaluation results. If the re-evaluation results show that the medical devices have defects that endanger personal safety, and the risks cannot be eliminated or controlled through technical improvement, modification of IFU and labels, or the risk-benefit ratio is unacceptable, the MAH should take the initiative to apply for the cancellation of the medical device registration certificate.
Medical Device Recall
Medical device recalls are classified into three categories based on the severity of the defects.
Additionally, there are recalls ordered by the NMPA. Following an investigation and evaluation, if the NMPA determines that the medical device manufacturer should recall defective medical device products but has not taken the initiative to do so, it may order the medical device manufacturer to recall the medical devices.
Periodical Risk Evaluation Report (PRER)
The periodic risk evaluation report (PRER) is a critical document for medical device. The MAH must complete the PRER of the previous year within 60 days after each full year for medical devices that are approved for registration or filing for the first time in China. The MAH of Class II and Class III medical devices, in particular, should submit via the National Medical Device Adverse Event Monitoring Information System, fill out the online submission form, and upload the PRER as an attachment. Class I medical device PRERs must be kept on file for future review. Before renewing the registration of Class II and Class III medical devices, the MAH must complete the PRER for the actual registration cycle.
Throughout the life cycle of the medical device, the data should be presented continuously and without interruption. Data sources include, for example, complaints, data from vigilance databases and literature, and so on.
The main content of the PRER includes:
- Basic product information: name of the medical device, model, specifications, registration certificate number, structure and composition, main components, intended use, validity period etc.
- Status of domestic and foreign registration,
- Risk control measures, such as the cessation of product production and sale, product recall, process improvement, design, technical requirements for the product, and the implementation of a re-evaluation of the medical device.
- Adverse event information, individual adverse events and group adverse events received by the MAH during the reporting period.
- Additional risk information, e.g. Data from literature research, product risk evaluation, key monitoring and re-evaluation.
- Product risk analysis. This section should analyze the comprehensive product risk situation from the perspectives of device design and development, production management, transport and storage, operation and use, maintenance, after-sales service, and so on, with a focus on the analysis of the main causes of adverse events, whether the characteristics of adverse events have changed, whether the reporting frequency of adverse events has increased, and the impact of changes in characteristics.
- Conclusion. The differences between the PRER results and previous reports must be demonstrated, as well as the acceptability of the differences. Furthermore, the risk management measures should be summarized and their necessity explained.
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